pms-Fluoxetine Contraindications

Hypersensitivity: pms-FLUOXETINE (fluoxetine hydrochloride) is contraindicated in patients with known hypersensitivity to the drug or the excipients of the product. For a complete listing, see Description.
Monoamine Oxidase Inhibitors: In patients receiving serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma). These reactions have also been reported in patients who have recently discontinued SSRI treatment and then started treatment on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome (e.g. serotonin syndrome). pms-FLUOXETINE should not be used in combination with a MAOI (including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue) which are less well-known examples of MAOIs) or within 14 days of discontinuing therapy with a MAOI.
Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should elapse after discontinuing treatment with pms-FLUOXETINE before starting a MAOI. Limited reports suggest that intravenously administered dantrolene or orally administered cyproheptadine may benefit patients experiencing such reactions. See Drug-Drug Interactions: Monoamine Oxidase Inhibitors under Interactions.
Thioridazine: Thioridazine should not be administered concomitantly with pms-FLUOXETINE or within a minimum of 5 weeks after pms-FLUOXETINE has been discontinued, nor should pms-FLUOXETINE be administered within 2 weeks after thioridazine has been discontinued.
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
An in vivo study suggests that drugs which inhibit P4502D6, including certain SSRI's such as paroxetine, fluoxetine and fluvoxamine, will elevate plasma levels of thioridazine. Therefore, pms-FLUOXETINE should not be used in combination with thioridazine. See Drug-Drug Interactions: Thioridazine under Interactions.